Transvaginal tube as an aid to laparoscopic surgery

ABSTRACT

A method of performing a laparoscopic hysterectomy treatment or other laparoscopic treatment on a patient, utilizes a transvaginal surgical device that includes a tube having a diameter greater than the patient&#39;s cervix, and an annular edge which lies substantially in a plane non-normal to its tubular axis, and a sealing structure capable of sealing the tube during surgery to maintain the pneumoperitoneum. The method includes introducing the device into the patient&#39;s vagina so that the annular edge defines a cervico-vaginal junction, and separating the cervix from the vagina at the defined cervico-vaginal junction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 10/400,692,filed Mar. 28, 2003, which is a continuation of application Ser. No.09/443,503, filed Nov. 19, 1999, which is a continuation-in-part ofapplication Ser. No. 08/586,856, filed Feb. 4, 1998, which is a Section371 of PCT/AU94/00630, filed Oct. 13, 1994.

FIELD OF THE INVENTION

This invention relates to a transvaginal tube which is particularlyuseful in laparoscopic surgery, and also to a procedure for the use ofsuch a tube.

BACKGROUND ART

Modern advances in laparoscopic surgical equipment have meant thatsurgeons are able to remove the uterus and/or ovaries laparoscopically,removing the need for a long abdominal incision.

A laparoscopic radical hysterectomy for cancer has evolved from theefforts of a few oncology centres with an interest in minimisinginvasive surgery. The operative technique is analogous to a modificationof the operation originally described by Wertheim and Meigs. Thelaparoscope surgeon passes a 10 mm laparoscope trans-abdominally througha sub-umbilical incision after establishing a pneumoperitineum. Usingtwo lateral portals the ovarian pedicles are divided down to the levelof the uterine arteries. The ureter is isolated and protected and theuterine vessels and parametrium are divided after mobilising thebladder. The next stage is to remove the uterus and close the vaginalvault so the pneumoperitoneum can be re-established for thelymphadenectomy. The lymph nodes are removed by plucking them from theirbed and dragging them out of the abdomen through the trans-abdominalwall port used for the grasping forceps.

Various medical commentators suggest that laparoscopically assistedradical hysterectomy (colloquially known as “keyhole Wertheims”) offersmany advantages. Patients go home earlier and the convalescence periodis shorter. The disadvantage is that the additional laparoscopic surgeryincreases operative time.

Plastic bags have been used to harvest ovaries in an attempt to minimisethe contamination of metastatic material through the ports. However,these are fiddly to use and can be difficult to drag out of theabdominal port. Nonetheless, one study has demonstrated that ordinaryplastic bags are just as effective as commercially available customisedbags and ovaries and omentum can be placed in a bag and deliveredthrough the vagina. This is an excellent refinement for ovarian surgerybut it is difficult to place multiple small nodes in several bags and besure of their origin.

SUMMARY OF THE INVENTION

The present invention provides a transvaginal tube, and a procedure forusing that tube, which is suitable for use in laparoscopic surgicaltechniques.

According to one aspect, the present invention provides a transvaginaltube adapted for insertion into the vaginal tract for theexteriorisation of intra-abdominal tissue, the tube having a diametergreater than the cervix opening and having a distal end and a proximalend, the proximal end being cut in a plane non-normal to the tubularaxis and being adapted to define a cervico-vaginal junction.

Preferably, the proximal end of the transvaginal tube is bevelled sothat the leading or anterior edge of the tube protrudes beyond theposterior edge. In this respect, the anterior edge is, for example, 1 to2 cm longer than the posterior edge. To avoid tissue damage in use, theedge of the tube surrounding the open bevelled end may be adapted tohave a smooth edge. This may, for example, be achieved by moulding orshaping the tube with smooth convex edges or by attaching a cover meansto the proximal end of the tube walls which blankets and provides asmooth surface over the wall of the bevelled open end of the tube.

The transvaginal tube may be formed of any material. However, the tubeis preferably made of a plastic material which provides a degree offlexibility.

Preferably, the tube is also substantially transparent. It will beappreciated that the tube may also be formed of opaque material but maycontain one or more transparent portals along the length of the tube.

The tube may be of any length and diameter. Preferably the tube is of agreater length than 5 cm and has a diameter of from 10 to 100 mm. Morepreferably, the tube is 25 to 50 cm in length and has a diameter of from30 to 50 mm.

To facilitate use in a sterile environment, the transvaginal tube ispreferably capable of withstanding sterilisation and the distal end ofthe tube may be sealed or open. Any means known in the art which iscapable of sealing the distal end of the tube may be employed in theinvention. For example, the distal end may be capped or plugged.Preferably the sealing means is capable of effecting a fluid tightclosure of the distal end of the tube to approximately 5 to 30 cm ofwater pressure but most preferably 15 cm of water pressure.

Alternatively, the distal end of the tube may be in a releasable sealingengagement with at least a valve means which when closed is capable offorming a fluid tight enclosure at the distal end of the tube toapproximately 5 to 30 cm of water pressure, and most preferably to 15 cmof water pressure. Any valve means known in the art which is capable ofachieving this may be employed in the invention. To facilitate use in asterile environment, the valve means is preferably capable ofwithstanding sterilisation.

When the distal end of the transvaginal tube is open, one or moresmaller bore tubes may be inserted into the transvaginal tube. Forexample, a smaller bore tube may be fitted into the end of thetransvaginal tube to promote washing of body fluids and tissue specimensfrom the proximal end of the interior of the transvaginal tube into aplastic collection bowl with or without the aid of suction when thetransvaginal tube is fitted within a subject. Alternatively there may bepassed into the transvaginal tube an intra-uterine manipulator which islonger than the internal length of the tube and which may be fixed byaids to the inside of the tube. The distal end of this manipulator maybe used to enter the cervix to allow manipulation of the cervixthroughout the surgical procedure of hysterectomy or adnexal surgery.

In another embodiment of the invention there is fixed in a concentricarrangement within the transvaginal tube a fluid tight channel throughwhich a telescope or light sources may be inserted while maintainingfluid pressure within the tube. Preferably that channel extends from thedistal end to the proximal end of the tube. The channel may be sealed atthe distal end of the tube. Alternatively, the distal end of the tubemay be adapted to house a portal which is capable of forming areleasable sealing engagement with the circumferential rim of the distalopen end of the channel providing the interior of the channel with ameans of communication with the exterior of the tube. The proximal endof the channel is preferably sealed.

Desirably the releasable sealing engagement between the tube and thechannel should be capable of withstanding approximately 5 to 30 cm ofwater pressure but most preferably 15 cm of water pressure. While such achannel may be suitable for telescopes and light sources it will beappreciated that other surgical instruments may be inserted in thechannel.

In a further embodiment, when the interior of the channel is incommunication with the exterior of the tube there is preferably providedat least a valve means inserted in the longitudinal wall of the tube.The valve means should be capable of withstanding 5 to 30 cm of waterpressure but most preferably 15 cm of water pressure.

In yet a further embodiment of the invention there is releasably engagedto the longitudinal wall of the tube at least a valve means and there ispassed in concentric arrangement through the distal end or longitudinalwall of the transvaginal tube and extending the length of the tube,smaller bore tubes which may, for example, provide passage forintra-uterine manipulators, tubes to promote irrigation of tissue,laparoscopic grasping forceps, laparoscopically directed staplingdevices or laparoscopically directed electro-coagulation diathermy,laser or ultrasonic scalpel devices. To facilitate use in a sterileenvironment the tube is preferably sealed at the distal end and ispreferably capable of withstanding sterilisation. Any means known in theart for sealing the valve means and the smaller bore tubes may beemployed with the invention. Preferably the tube comprises at least avalve means and one or more narrow diameter tubes, and when sealed atits distal end, is capable of withstanding approximately 5 to 30 cm ofwater pressure but most preferably 15 cm of water pressure.

The present invention may be employed in laparoscopic surgery forexposure of the vaginal fornices, as an aid to separation of the bladderfrom the vagina, for division of the vagina by electro-coagulationdiathermy, laser or ultrasonic scalpel, and as a conduit forexteriorising tissue from the abdominal pelvic cavity. In this respect,the tissue may be the uterus and/or its adnexal, ovarian cysts, andparticular pelvic lymph nodes. The present invention may also beemployed as an exit for fluid such as blood and irrigation fluid andsmoke or vapour from the abdominal pelvic cavity, as a splinting deviceto present and expose the dividing edges of the vagina, to facilitatesuture closure as a splinting device in the vagina, to expose thevaginal fornices and lateral edge at bladder neck surgery, for insertionof sling devices and as a portal for telescopes or light tubes into thevagina while keeping them separate from the vaginal wall and exposingthe vaginal mucoso through the substantially transparent walls of ortransparent portals in the tube.

The tube may be used to outline the vagina at open surgery. In thesecases the valved end (distal) is not required.

According to a second aspect of the invention there is provided a methodfor laparoscopic hysterectomy treatment comprising the steps of:

(i) introducing a tube as aforedescribed into the vagina of a patient sothat the proximal end of the tube circumscribes the cervico-vaginaljunction;

(ii) separating the cervix from the vagina; and

(iii) mobilising a surgical specimen and inserting it into the proximalend of the tube.

Preferably the cervix is separated from the vagina by the steps of:

(i) exposing and holding the cervix with laparoscopic graspingmanipulators;

(ii) inserting a knife or diathermy knife to the proximal end of thetube;

(iii) rotating the tube so the plane non-normal to the tubular axisstretches the vagina and at the same time cutting the cervico-vaginaljunction as the tube is rotated.

As well as being most commonly used for simple laparoscopichysterectomy, the present invention may also be used in laparoscopicradical hysterectomy and pelvic lymph node dissection.

BRIEF DESCRIPTIONS OF THE DRAWINGS

The present invention will now be described in relation to variousexamples, which in turn refer to the embodiments of the transvaginaltube as illustrated in the FIGS. 1 to 3. However, it must be appreciatedthat the following description is not to limit the generality of theabove description.

The invention will be more fully understood in the light of thefollowing description of two specific embodiments. The description ismade with reference to the accompanying drawings in which:

FIG. 1 is an isometric view of a transvaginal tube according to a firstembodiment of the invention;

FIGS. 2 and 3 are sectional views of the proximal end of thetransvaginal tube shown in FIG. 1;

FIG. 4 is a sectional view of the proximal end of the transvaginal tubeof FIG. 1 in situ;

FIG. 5 is a view similar to FIG. 1 of a transvaginal tube according to asecond embodiment of the invention;

FIG. 6 is a fragmentary side elevational view of the tube depicted inFIG. 5, showing the tube body, the headpiece, and the headcap asseparated components;

FIG. 7 is a cross-sectional view of the assembled tube of FIGS. 5 and 6;

FIG. 8 is an isometric view of the headcap of the embodiment of FIGS. 5to 7;

FIG. 9 is a bore tube for use with an embodiment of the invention; and

FIG. 10 is an intra-uterine manipulator for use with an embodiment ofthe invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The embodiment of FIGS. 1 to 3 relates to a transvaginal tube 10 whichhas a body defined by a tube 11 which has a proximal end 12 and a distalend 14. The distal end 14 engages a valve means or headpiece 16 at ajunction 18. The tube body 11 is a relatively stiff yet flexible plasticmaterial such as polypropylene. Alternatively, a medical grade liquidsilicone rubber is suitable. The junction 18 is provided by theresilience of the plastic material allowing for a force fit engagementof the distal end 14 of the tube 10 with one end of the valve means 16so as to provide a substantially fluid tight engagement.

FIGS. 2 and 3 show sectional side views of the proximal end 12 of thetube 10 including an anterior edge 20 and a posterior edge 22. It willthus be apparent that the proximal end 12 is cut at an angle non-normalto the longitudinal axis of the tube. This provides the bevelledappearance that is apparent in FIGS. 2 and 3 and results in the anterioredge 20 being 1.5 cm beyond the posterior edge 22.

FIG. 4 shows the proximal end 12 of the tube 10 located insitu at thecervico-vaginal junction 24. When located in this position, the vaginalwalls 26 envelop the tube 10 forming a seal around the tube. The cervix28 protrudes into the proximal end 12 of the tube 10 and the uterus 30lies above and exterior to the anterior edge 20. Thus it will beapparent that the proximal end 12 is adapted to circumscribe thecervico-vaginal junction.

A second embodiment of transvaginal tube 110 is illustrated in FIGS. 5to 8 and again includes a tube body 111, of material similar to tubebody 11, having a proximal end 112 and a distal end 114. Distal end 114engages a valve means or headpiece 116 in a force fit at a junction 118.Proximal end 112 is again cut at an angle inclined to the normal to thelongitudinal axis 125 of the tube. Insitu, the proximal end 112circumscribes the cervico-vaginal junction in the manner depicted inFIG. 4 for the first embodiment.

This second embodiment differs from the first in several respects. Mostapparent is the very slight (large radius) curvature of the tube body111 and of its longitudinal axis 125, except for an end region 123 atdistal end 114 that serves as a socket for headpiece 116, so thatposterior edge 122 at proximal end 112 is on the inside of the curve.The longitudinal axis 125 of the tube body 111 has a radius of curvaturethat generally follows the curve of the pelvic axis. This large radiuscurvature enhances both the ease of insertion of the tube and thereliability of engagement of proximal end 112 about the cervico-vaginaljunction, and has the advantage that it presents the proximal end 112 upto the examining surgeon working in the abdominal cavity.

It is preferred that most of tube body 111 is transparent and externallysmooth, save for an externally slightly roughened and therefore frostedor opaque region 130 adjacent proximal end 112, indicated bycross-hatching in FIG. 6. This region 130 grips the vagina better andthereby aids in presenting the vagina for suture closure.

Socket end region 123 is straight and made relatively rigid compared totube body 111 by several integral annular external ribs 132, to enhancethe press-fit about a smaller diameter spigot end 162 of headpiece 116.The rest of tube body 111 is substantially stiff but exhibits a degreeof flexibility and deformability to facilitate vaginal insertion, and toprevent damage to the vaginal walls that a rigid tube might cause. Tubebody 111 is slightly tapered, ie of progressively diminishingthickness—from a stepped peripheral shoulder 126 marking the inner edgeof socket end region 123 to a point 127 a little more than half-wayalong the tube body. This taper initially facilitates mould extraction,but is also thought to be useful for imparting a graded pressure on thevaginal walls to prevent gas loss. Tube body 111 also carries a smallcircular aperture 128 close to proximal end 112 that is provided as anend-point for a suture holding slit should a surgeon wish to cut such aslit for a given procedure: the aperture will guard against running ofthe slit as a tear along the tube.

Headpiece 116 may be moulded in, eg, medical grade polypropylene and hasa generally tubular, larger diameter main body 164 linked to theaforementioned spigot end 162 of smaller diameter. Both are of annularcross-section. Main body 164 has an externally flat web handle 166, withcutout 167, on a diametral plane, and an external radial nipple 168 toreceive a cap or a 2-way bleeder valve for smoke or gas evacuation to anunderwater seal. Nipple 168 is normally internally closed. Handle 166facilitates insertion and positioning of tube 110 during surgery, and isfurthermore positioned in a manner enabling it to serve as anorientation node for the tube when introduced into a patient: it isaligned with slot 129 and posterior edge 122. A small hole 169 in handle166 is useful for attachment of retention tapes to prevent the tubefalling out of the vagina.

The rear or outer open end of main body 164 of headpiece 116 isselectively sealingly closed by a headcap 170 comprising a moulding of ahighly flexible material such as medical grade liquid silicone rubber.

Headcap 170 has a closure disc 172 linked to a ring 174 by a thin webhinge 175: ring 174 retains the headcap on headpiece main body 164.Closure disc 172 has an annular internal channel 176 at its peripherywith a rounded skirt 173 (FIG. 7). Channel 176 is sealingly engageablewith a bead 165 at the open rim of headpiece main body 164. Channel 176extends about a central web diaphragm 178 that has two, one small andone large, generally conical portal structures 180, 181. Portablestructures 180, 181 can serve as valves and have respective end slits182, 183 that are normally biased closed against fluid flow, by theresilience of the material, but may deform about and seal against aninserted surgical tool or other device. Such tools or devices include asmaller bore tube 900, as shown in FIG. 9, to promote washing of bodyfluids and tissue specimens from the interior of the tube, with orwithout the aid of suction, when the transvaginal tube is fitted withina subject, or an intra-uterine manipulator 1000, as shown in FIG. 10,that is longer than the internal length of the tube and may be fixed byaids to the inside of the tube. As mentioned earlier, the distal end ofthis manipulator may be used to enter the cervix to allow manipulationof the cervix throughout the surgical procedure of hysterectomy oradnexal surgery.

By applying suction to the tube interior at one of portal structures180, 181, a surgical specimen may be very effectively sucked into thetube without any need to use grasping instruments. The specimen may be,eg. the cervix and uterus, or, a deflated cyst where the cyst contentshave been extracted with a needle

Portal structures 180, 181 may further form a releasable sealingengagement with a fluid tight channel through which a telescope or lightsource may be inserted, as also referred to earlier.

Headpiece 116 and headcap 170, when assembled to tube body 111,preferably seal the end of the tube body to an extent capable of forminga fluid tight closure to approximately 5 to 30 cm water pressure, mostpreferably to 15 cm water pressure.

Several examples of gynaecological laparoscopic surgical proceduresutilising the tube 10 or 110 will now be described.

EXAMPLE 1

A tube 10, 110 made of firm or flexible smooth transparent plastic, witha valve 16, 116 mounted at one end, is sterilised in preparation forgynaecological laparoscopic surgery. When the patient is anaesthetised,positioned, cleansed and draped according to local custom, the tube ispassed through the female vagina. The proximal end 12, 112 of the tubecircumscribes the cervix from the vagina as depicted in FIG. 4. The tubeis removed to allow the uterus and appendages to be exteriorised,following which the tube is replaced and the proximal end of the tube isintraperitoneal. The distal end 14, 114 is closed with a valve orheadpiece 16, 116 and the pneumoperitoneum is maintained. No otherdevice is needed to maintain the pneumoperitoneum but the tube issecured in place. Any fixation is acceptable but it is usually held byan assistant surgeon or one end is rested on a table. The tube ispositioned according to need.

The proximal end of the tube when located intra-abdominally lies distalabove the exteriorised end to allow surgical specimens to pass down thetube by gravity. The proximal end is placed close to the vaginal edgespointing slightly to the appropriate pelvic side wall during a pelviclymphadenectomy but is placed further through the vagina for specimenremoval, eg. ovarian cysts, lymph nodes and ectopic pregnancies. Thesurgical specimen is mobilised and placed in the mouth of the tube. Itis exteriorised as it slides down the tube. In this respect tissue maybe encouraged to pass down the tube by washing it with irrigation fluid.

Blood and irrigation fluid that has collected in the cul de sac may alsobe exteriorised through the tube. The distal end valves 180, 181 can beused to aspirate blood or body fluids from the tube or the cul-de-sac ofthe pelvis with an aspirating cannula. At the completion of thelaparoscopic surgery the tube would be removed and the vagina closed.

EXAMPLE 2

The tube was sterilised with ethylene oxide gas. However, it will beappreciated that any method of sterilisation may be employed tosterilise the apparatus.

The first steps of a true laparoscopic hysterectomy are to secure anddivide the ovarian, uterine and cervical branch of the uterine arteryand reflect the bladder. The uterus is separated from the vagina and itsuterosacral ligaments using the tube. The tube diameter depends on thepatient. A 5 cm diameter tube is ideal for multiparous and overweightwomen but a smaller 4 or 3.5 cm diameter tube is needed forpostmenopausal and nulliparous women to make it fit the vagina. It isinserted through the introitus and advanced to the cervix. This elevatesand defines the cervicovaginal junction and further bladder mobilisationcan be performed at this stage if more vagina exposure is necessary. Thetube position also facilitates identification of the uterine vessels fora safe point for electrocoagulation or suture occlusion and division ofthe vessels.

Once the vaginal wall is exposed the diathermy knife/scissors followsthe rim of the tube circumcising the vagina and dividing the uterosacralligaments. Holding the exposed cervix with laparoscopic grasping forcepsand rotating the tube so that the longer bevelled end is beneath theknife puts the vagina under further local stretch. This reduces localblood flow and makes uni-polar electrocoagulation particularlyefficient.

After the cervix has been separated from the vagina it is held withlaparoscopic grasping forceps and fed in the open end of the vaginaltube. When the tube is slowly removed vaginally the cervix follows. Thegas is then temporarily released from the peritoneal cavity to preventany explosive spray of body fluids from the introitus as the tube andspecimen are removed. If the uterus is too large to be totally insertedin the tube, just the cervix is inserted and the specimen is steered tothe introitus where it can be grasped by a vulsellum and removed.

Another advantage of the tube is that the vault can be suturedlaparoscopically without resorting to intracorporial knots. Replacingthe tube in the vagina supports and exposes the vaginal edges. The edgescan be sutured by placing a needle, preferably taper-cut with amonofilament absorbable suture, in the tube so the trailing end remainsintravaginal. The needle is recovered from the tube and the first stitchpasses through the inside of the vagina to the peritoneal surface. Thevault is closed with a purse string or a linear closure from one end tothe other and back again. When the suturing is complete the needle isreturned to the transvaginal tube so that both ends of the suture are inthe vagina. The tube is withdrawn leaving the needle and trailing end ofthe suture at the introitus so the operator can lean over and tie theends intravaginally. Other intracorporeal or extracorporeal techniquesof knot tying may be employed.

Results

The tube was used to separate the vagina from the cervix in forty casesby five different surgeons, thirty-four of these were simplelaparoscopic hysterectomies for benign diseases in women with limitedvaginal access, three were hysterectomies plus pelvic lymphadenectomyfor endometrial cancer and three were modified radial hysterectomies forearly cervical cancer. In twenty cases the vault was closedlaparoscopically. There were no intraoperative complicationsattributable to the tube.

EXAMPLE 3

Use of the transvaginal tube as an aid to bladder neck surgery.

At either open or laparoscopic surgery, designed to elevate the bladderneck for treatment of stress incontinence of urine in the female, byeither the Birch, Cato-Murray or similar procedure, the transvaginaltube previously described can also be used without the valve at thedistal end to enhance bladder neck surgery. The tube may be any lengthfrom 5 cms to 35 cm in length, made of the same clear, rigid orsemi-rigid plastic as previously described.

At that time in the procedure when the para-vesical area is beingprepared to expose the lateral vaginal fornices, the tube is insertedwith a telescope, either a direct (0 degrees) or a forward oblique typefor example, with a 30 degree angle.

The tube acts to expand the vaginal walls, particularly the vaginalfornices so that they are made more prominent and fixed so that definiteidentification from either the open procedure or the retro-peritoneallaparoscopic or trans-peritoneal laparoscopic approach, is enhanced. Theview of the vaginal fornix on the left and right is further enhanced bytrans-illumination from the vaginal aspect by the telescope light. Thisenables improved exposure and ability to see and reflect the bladderwall from the vaginal fornices from above because of thetrans-illumination effect. It also allows enhanced identification of thepara vaginal venous plexus so that the large veins can be more easilyavoided by the needle and suture placed from above into the vaginalwall. Placing of the Birch or Cato-Murray type suture through thesub-mucosal layers of the vagina is made easier as the large veins ofthe para vaginal wall are made more identifiable by trans-illumination.With the vaginal telescope within the tube, connected to a camera and ascreen, the appropriate site selected for insertion of the suture can beseen through the wall of the tube merely by compressing the wall withthe outer part of the needle before insertion of the suture. The tubeallows a broader and more secure bite of the wall to be taken andpuncture of the mucosal or epidermal layer by the needle can beimmediately recognised on the vaginal telescope screen. This supersedesthe current practice of an assistant placing a thimble covered finger inthe right and left vaginal fornices while the operator places the suturein the area of the vagina over the assistant's finger. With the vaginalfornices secured, tension can then be placed on the securing sutures andan appreciation of symmetrical bladder neck elevation can be made on thescreen. At present, other than by the assistant's palpation as anassessment of the elevating effect, the surgeon has no idea of thedegree of elevation or the right or left symmetry that is being obtainedby the procedure.

In that case, full thickness penetration by the non-absorbable suturecan only be discerned by the operator or the assistant feeling contactwith the metal needle with the metal thimble or noting bleeding on theassistant's glove which would indicate full thickness puncture. In thatcase, the needle has to be withdrawn and re-inserted into thesub-mucosal dermis of the vagina.

It should be appreciated that the scope of the present invention neednot be limited to the particular scope of the embodiment describedabove.

EXAMPLE 4 Results

In a comparative study of Laparoscopic Versus Open Surgery in themanagement of Endometrial cancer reported by the Western AustralianGynecologic Cancer Service at the Annual Meeting of The AustralianSociety of Gynecologic Oncologists in April 1999, 126 cases treated byLaparoscopic Hysterectomy using a transvaginal tube (according to anembodiment of the invention as disclosed and claimed in the parentapplication) were compared to 107 cases treated by the traditional“open” Laparotomy abdominal Hysterectomy procedure. The followingresults were reported. Laparoscopic Open Mean Weight (Kgs) 81 72Operative Time (Mins) 139 137 Post Operative Morbidity (No. of Cases)Urinary Tract Infection 1 11 Wound Infection 0 4 Pneumonia 1 2 PulmonaryEdema 0 2 Venous Thrombosis 1 1 Stroke 0 1 Death 0 2 Post Operative Daysin Hospital (mean) 3.4 8.5 Percent cured at mean follow up of 88.9 88.723 and 20 months respectively

It will be understood that the invention disclosed and defined hereinextends to all alternative combinations of two or more of the individualfeatures mentioned or evident from the text or drawings. All of thesedifferent combinations constitute various alternative aspects of theinvention. Various changes and modifications may be made to theembodiments described and illustrated without departing from the presentinvention.

1. A method of performing a laparoscopic hysterectomy treatment or otherlaparoscopic treatment on a patient, utilising a transvaginal surgicaldevice that comprises a tube having a diameter greater than thepatient's cervix, and an annular edge which lies substantially in aplane non-normal to its tubular axis, and a sealing means capable ofsealing the tube during surgery to maintain the pneumoperitoneum, saidmethod comprising: (i) introducing said device into a patient's vaginaso that the annular edge defines a cervico-vaginal junction; and (ii)separating the cervix from the vagina at said defined cervico-vaginaljunction.
 2. A method according to claim 1-wherein said separating ofthe cervix from the vagina is effected intra-abdominally andlaparoscopically.
 3. A method according to claim 2 further comprisinglaparoscopically suturing the vault of the vagina following saidseparating step, with the tube in position in the vagina to support thevaginal edges.
 4. A method according to claim 3 wherein the needle forsaid suturing is introduced through the tube and returned to the tubeafter completion of the suturing.
 5. A method according to claim 2,further comprising: (iii) mobilising a surgical specimen resulting fromsaid separating step into an end of the tube which is adjacent saidannular edge; and
 6. A method according to claim 5 further comprising,after said mobilising step: (iv) withdrawing the tube, with saidsurgical specimen contained therein, from the vagina.
 7. A methodaccording to claim 6 further comprising, after step (iv); (v)reintroducing the tube into the vagina and laparoscopically suturing thevault of the vagina, with the tube in position in the vagina to supportthe vaginal edges.
 8. A method according to claim 7 wherein the needlefor said suturing is introduced through the tube and returned to thetube after completion of the suturing.
 9. A method according to claim 5wherein said mobilising of the surgical specimen is effected bylaparoscopically grasping the specimen and feeding it into the tube. 10.A method according to claim 5 wherein said mobilising of the surgicalspecimen is effected at least in part by applying suction via the tube.11. A method according to claim 2 wherein said laparoscopic separationof the cervix from the vagina is effected by electro-coagulationdiathermy.
 12. A method according to claim 11 wherein saidelectro-coagulation diathermy is effected by: exposing and holding thecervix with a laparoscopic grasping manipulators, inserting a knife ordiathermy knife to the proximal end of the tube, and rotating the tubeso that the annular edge non-normal to the tubular axis stretches thevagina and locally reduces blood flow, and at the same time cutting thecervico-vaginal junction as the tube is rotated.
 13. A method accordingto claim 5 wherein said laparoscopic separation of the cervix from thevagina is effected by electro-coagulation diathermy.
 14. A methodaccording to claim 13 wherein said electro-coagulation diathermy iseffected by: exposing and holding the cervix with a laparoscopicgrasping manipulators, inserting a knife or diathermy knife to theproximal end of the tube, and rotating the tube so that the annular edgenon-normal to the tubular axis stretches the vagina and locally reducesblood flow, and at the same time cutting the cervico-vaginal junction asthe tube is rotated.
 15. A method according to claim 13 furthercomprising, after step (iv); (v) reintroducing the tube into the vaginaand laparoscopically suturing the vault of the vagina, with the tube inposition in the vagina to support the vaginal edges.
 16. A methodaccording to claim 15 wherein the needle for said suturing is introducedthrough the tube and returned to the tube after completion of thesuturing.
 17. A method according to claim 13 wherein said mobilising ofthe surgical specimen is effected by laparoscopically grasping thespecimen and feeding it into the tube.
 18. A method according to claim1, further comprising: (iii) mobilising a surgical specimen resultingfrom said separating step into an end of the tube which is adjacent saidannular edge; and
 19. A method according to claim 18 further comprising,after said mobilising step: (iv) withdrawing the tube, with saidsurgical specimen contained therein, from the vagina.
 20. A method ofperforming a laparoscopic hysterectomy treatment or other laparoscopictreatment on a patient, utilising a transvaginal surgical device thatcomprises a tube having a diameter greater than the patient's cervix,and a sealing means capable of sealing the tube during surgery tomaintain the pneumoperitoneum, said method comprising: (i) introducingsaid device into a patient's vagina; (ii) separating the cervix from thevagina; and (iii) mobilising a surgical specimen resulting from saidseparating step into an end of the tube which is adjacent said annularedge.
 21. A method according to claim 20, further comprising: (iv)withdrawing the tube, with said surgical specimen contained therein,from the vagina.
 22. A method according to claim 21 wherein saidseparation of the cervix from the vagina is effected intra-abdominallylaparoscopically at a cervico-vaginal junction defined by an annularedge at an end of said tube.
 23. A method according to claim 22 whereinsaid laparoscopic separation of the cervix from the vagina is effectedby electro-coagulation diathermy.
 24. A method according to claim 23wherein said electro-coagulation diathermy is effected by: exposing andholding the cervix with a laparoscopic grasping manipulators, insertinga knife or diathermy knife to the proximal end of the tube, and rotatingthe tube so that the annular edge stretches the vagina and locallyreduced blood flow, and at the same time cutting the cervico-vaginaljunction as the tube is rotated.
 25. method according to claim 21further comprising, after step (iv); (v) reintroducing the tube into thevagina and laparoscopically suturing the vault of the vagina, with thetube in position in the vagina to support the vaginal edges.
 26. Amethod according to claim 25 wherein the needle for said suturing isintroduced through the tube and returned to the tube after completion ofthe suturing.
 27. A method according to claim 20 wherein said mobilisingof the surgical specimen is effected by laparoscopically grasping thespecimen and feeding it into the tube.
 28. A method according to claim21 wherein said mobilising of the surgical specimen is effected at leastin part by applying suction via the tube.
 29. A method according toclaim 23 wherein said mobilising of the surgical specimen is effected bylaparoscopically grasping the specimen and feeding it into the tube.